In Thai populations, many ARV levels are very high. We believe that 600 mg efavirenz is too high for Thai people and would like to see the pharmacokinetic data and safety and efficacy of efavirenz at 400 mg.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Age > 18 years of age or older with HIV-1 infection

Who are on stable PI-based highly active antiretroviral therapy and have HIV-1 RNA <50 copies/ml within 6 months.

No active opportunistic infection.

Sexually active subjects must be willing to use an effective form of birth control.

Able to provide written informed consent.

Exclusion Criteria:

Pregnant or breast-feeding females are excluded.

Inability to understand the nature and extent of the study and the procedures required.

ALT/ AST more than 5x upper limit

Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.

Use of concomitant medication that may interfere with the pharmacokinetics of efavienz

History of sensitivity/idiosyncrasy to the drug or chemically related compounds which may be employed in the study.

Active drug abuse

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00476424